UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A prospective study of esomeprazole treatment for ulcer healing after gastric endoscopic submucosal dissection
Title of the study (Brief title)	Effect of esomeprazole for post ESD ulcers
Region	Japan

Condition
Condition	early gastric cancer
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to investigate the healing rates of post-ESD ulcers in response to the 2-week or 4-week esomeprazole treatment.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	the healing rates of post-ESD ulcers 29 days after ESD
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Administration of 20mg/day esomeprazole for 2 weeks and 300mg/day rebamipide for 8 weeks
Interventions/Control_2	Administration of 20mg/day esomeprazole for 4 weeks and 300mg/day rebamipide for 8 weeks
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who will undergo ESD for early gastric cancer
Key exclusion criteria	age below 20, active gastric or duodenal ulcers, hypersensitivity to esomeprazole or rebamipide, severe heart disease, severe renal dysfunction, severe liver dysfunction, expectant mothers, patients taking NSAIDs, anticoaglant or antiplatelet drugs and so on
Target sample size	200

Research contact person
Name of lead principal investigator	Yasunari Nakamoto
Organization	University of Fukui Hospital
Division name	Department of Gastroenterology
Address	23-3 Matsuokashimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui, Japan 910-1193
TEL	0776-61-8351
Email	nakamoto-med2@med.u-fukui.ac.jp

Public contact
Name of contact person	Hiroyuki Suto
Organization	University of Fukui Hospital
Division name	Department of Gastroenterology
Address	23-3 Matsuokashimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui, Japan 910-1193
TEL	0776-61-8351
Homepage URL
Email	hrykstu@u-fukui.ac.jp

Sponsor
Institute	University of Fukui Hospital
Institute
Department

Funding Source
Organization	Second department of Internal Medicine, University of Fukui
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2013 Year 05 Month 27 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 10 Month 01 Day
Anticipated trial start date	2013 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 05 Month 23 Day
Last modified on	2017 Year 10 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000012622